FLUAD inactivated influenza vaccine (surface antigen) suspension for injection, adjuvanted, 0.5 mL syringe 2019

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Influenza virus haemagglutinin, Quantity: 30 microgram/mL

제공처:

Seqirus Pty Ltd

약제 형태:

Injection, suspension

구성:

Excipient Ingredients: sodium chloride; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate; squalene; polysorbate 80; sorbitan trioleate; sodium citrate dihydrate; citric acid monohydrate; water for injections

관리 경로:

Intramuscular

패키지 단위:

1 x 0.5mL pre-filled syringe

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

제품 요약:

Visual Identification: MILKY-WHITE SUSPENSION.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2018-11-02

환자 정보 전단

Consumer Medicine Information (AUST R 90339 & AUST R 306718)
Page 1 of
4
FLUAD

Inactivated Influenza Vaccine, Adjuvanted
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUAD
®
.
It does not contain all the available
information.
It does not take the place of talking
to your doctor, nurse or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your
doctor has weighed the risks of you
having FLUAD
®
against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
FLUAD
®
, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT FLUAD
® IS USED FOR
FLUAD
®
is a vaccine used to help
prevent certain types of influenza or
“flu”. It is recommended for people
aged 65 years and over.
It is especially beneficial in people
aged 65 and over with
cardiovascular disease, respiratory
disease or diabetes and those who
are considered to have an
increased risk of complications
from influenza.
Influenza is a sudden respiratory
infection caused by a virus. It is
usually spread from one person to
another by small droplets from
coughs and sneezes. The virus
enters the nose or throat and may
spread to the lungs. It is very
contagious. There are several kinds
of influenza viruses however they
all produce similar illness. Influenza
is characterised by a sudden onset
of headache, generalised aches
and pain, fever that may be
followed by a sore throat, a cough
and a runny nose. The severity and
types of symptoms can vary. Most
people recover in about a week;
however, infection with influenza in
some people can lead to serious
illness, especially the elderly and
those who are “run down” or are in
poor health.
Vaccination against influenza helps
prevent infection with influenza and
to control the spread of the
disease.
_HOW IT WORKS _
FLUAD
®
works by causing your body
to produce its own protection
against the three types of influenza
virus it is made from. It does this by
making substances ca

제품 특성 요약

FLUAD
®
Product Information
AUST R 90339, AUST R 306718
Version 20190325-02-
Page 1 of 11
_AUSTRALIAN _
_PRODUCT _
_INFORMATION _
_– _
_FLUAD_
_®_
_ _
_(INFLUENZA _
_VIRUS _
_HAEMAGGLUTININ). _
1.
NAME OF THE MEDICINE
FLUAD
®
Inactivated influenza vaccine (surface antigen), suspension for
injection, adjuvanted;
containing Influenza virus haemagglutinin as active ingredient.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluad
®
is a purified, inactivated, surface antigen influenza vaccine,
adjuvanted with
MF59C.1 in a milky-white suspension for injection.
Each 0.5 mL dose contains influenza virus surface antigens of each of
three purified
surface antigens representative of the influenza virus types expected
to circulate in the
Southern Hemisphere winter according to WHO recommendations for the
2019
season:
-
A/Michigan/45/2015 (H1N1) pdm09 - like virus (A/Singapore/GP1908/2015
(IVR-180)):
15 micrograms HA* per dose
-
A/Switzerland/8060/2017 (H3N2) – like virus (
A/Brisbane/1/2018 (X-311)):
15 micrograms HA* per dose
-
B/Phuket/3073/2013 – like virus (B/Phuket/3073/2013 (BVR-1B)):
15 micrograms HA* per dose
*HA = haemagglutinin
Fluad
®
vaccine is prepared from virus grown
in embryonated hens’ eggs and
inactivated with formaldehyde before purification and combination with
MF59C.1, an
adjuvant known to increase the immunogenicity of vaccines. MF59C.1
contains the oil
squalene which is obtained from shark liver and is also found in
humans as a metabolite
of cholesterol and as a normal component of cell membranes.
The type and amount of viral antigens in Fluad
®
conform to the requirements of the
Australian Influenza Vaccine Committee for the 2019 Southern
Hemisphere Influenza
season. The strains chosen for vaccine manufacture are endorsed by the
Australian
Influenza Vaccine Committee as being antigenically equivalent to the
reference virus.
EXCIPIENTS
For full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
FLUAD
®
is a milky-white suspension for intramuscular injection.
4.